Model Number KIT, RITE AID TMX METERMG/DL |
Device Problem
Image Display Error/Artifact (1304)
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Patient Problem
Urinary Frequency (2275)
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Event Date 09/30/2022 |
Event Type
Injury
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Manufacturer Narrative
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Internal report reference number: (b)(4).Adverse event report is being submitted due to symptoms related to diabetes: frequent urination.Meter and test strips were not returned for evaluation.Note: manufacturer contacted customer in several follow-up calls to ensure the customer's condition had improved and that the replacement products resolved the initial concern - unable to establish contact with customer at this time.
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Event Description
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Consumer reported complaint for error message (e-4).The e-4 error occurred when a test strip was inserted into the true metrix meter.Customer did recall the product had been dropped/mishandled.At the time of the call the customer reported experiencing frequent urination; medical attention was not needed at the time.The test strip lot manufacturer¿s expiration date is 01/26/2024; product storage and open vial date were not disclosed.During the call, a back to back blood test was not performed by the customer.
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Manufacturer Narrative
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Sections with additional information as of 17-nov-2022: h6: updated fda¿s type, findings and conclusions codes.H10: meter was not returned for evaluation.Test strips were not returned for evaluation.Retention testing was performed using test strips from the same lot.Retention strip lot tested within specifications.Most likely underlying root cause: mlc-047: user induced contamination.
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Search Alerts/Recalls
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